FDA to Assess New Regulatory Endpoints for Four Disease Areas
Posted 02 August 2012 | By
The US Food and Drug Administration (FDA) has announced a four-day meeting to discuss clinical endpoints potentially capable of being used to support future drug development in four therapeutic areas.
The 19-24 September workshop, entitled "Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT)," is intended to discuss issues related to endpoints for eosinophilic esophagitis, pediatric and adult inflammatory bowel disease (IBD) and parenteral nutrition-associated liver disease.
In its 2 August Federal Register posting, FDA notes each day will be devoted to a single disease area, with analysis focusing on biomarkers, patient-reported outcomes, disease history, extrapolation of efficacy data, the timing of endpoint assessment and safety outcomes measures, depending on each disease.
FDA - Public Workshops: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics